R&d Document Specialist Ii - Chelmsford, United States - Teleflex

Teleflex

Verified Company

Chelmsford, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Date:
Apr 18, 2024

Location:
Chelmsford, MA, US

Company:
Teleflex

Expected Travel:
Up to 10%

Requisition ID: 10227

About Teleflex Incorporated
The Interventional business unit at Teleflex offers innovative medical devices for coronary and peripheral vascular diseases. They focus on complex coronary and peripheral interventions, vascular access, specialty biologic treatments, and cardiac assist. Their R&D team is dedicated to developing new technologies to help critically ill patients. Join their dynamic team and be part of making a difference in patients' lives.

Position Summary

The R&D Document Specialist plays a crucial role in managing Teleflex products across Product Lifecycles Management (PLM) for R&D. This role involves preparing, evaluating, and expediting R&D documents using Quality Management Systems (QMS) and Enterprise Resource Planning (ERP) systems. The specialist ensures R&D documents are complete, accurate, and compliant within these systems, acting as a Subject Matter Expert (SME) for R&D in PLM and document control processes.

Principal Responsibilities

R&D Subject Matter Expert in document change control in PLM systems
Partner with R&D to guide ECO/COs in preparing, routing, and approving documentation in QMS/ERP systems
Support creating New Product Development (NPD) documentation in QMS/ERP systems for R&D projects
Identify and implement best practices in document control for R&D NPD projects
Create reports for ECO/CO accuracy and approvals in QMS for R&D
Assist in monitoring process effectiveness and recommend improvements in PLM document control systems
Generate and update Global Trade Identification Number (GTIN) information in applicable systems
Provide customer service to cross-functional areas
Participate in projects and provide audit and training support as needed

Education / Experience Requirements

Bachelor's or technical degree in related field, degree preferred
3+ years of experience in medical device design and development
5+ years of experience in document control using PLM and ERP software, Oracle Agile/SAP preferred
Working knowledge of Microsoft Word, Excel, Outlook, Adobe Acrobat

Specialized Skills / Other Requirements

Excellent written and oral communication skills
Detail oriented and self-directed with excellent time management skills
Advanced knowledge of quality systems and compliance processes
Advanced proficiency in PLM and ERP software
Ability to work collaboratively and independently
Autonomy to prioritize and execute projects/tasks with minimal oversight

Competencies

Instills Trust: Builds confidence and trust through honesty and integrity
Courage: Addresses difficult issues and provides feedback when needed
Decision Quality: Makes timely decisions to keep the organization moving forward
Plans and Aligns: Sets objectives aligned with organizational goals and plans effectively
Cultivates Innovation: Introduces new and unique ideas to drive success